(15 days)
The VascuView ultrasound system provides ultrasound imaging of peripheral vascular structures in order to provide for ultrasound guidance for placement of needles and catheters in these structures. The VascuView ultrasound system is not intended for fetal or ophthalmic applications.
The VascuView ultrasound system provides ultrasound imaging of peripheral vascular structures in order to provide for ultrasound guidance for placement of needles and catheters in these structures. The VascuView system consists of the following components: Ultrasound Probe and Cable, Tablet PC, VascuView Software.
Here's a breakdown of the acceptance criteria and study information for the VascuView Ultrasound System based on the provided K080049 510(k) summary:
This device is an ultrasound system and its performance evaluation often relies on meeting safety standards and demonstrating equivalent physical characteristics to predicate devices, rather than clinical performance metrics typical of AI/ML devices. Therefore, a direct mapping to typical AI acceptance criteria like sensitivity/specificity or human-AI reader performance is not explicitly present in the provided documentation, as this is an older submission for a traditional medical device.
Acceptance Criteria and Device Performance
The acceptance criteria for the VascuView Ultrasound System appear to be primarily focused on safety, electromagnetic compatibility, and demonstrating comparable or superior physical and performance characteristics to its predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety Standards Compliance | Compliant with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, and IEC 60601-2-37 (including acoustic output limits). |
| Measurement Accuracy | "slightly better measurement accuracy of ±2% plus 0.5% full scale" compared to predicate device's ±2% plus 1% full scale. |
| Software Validation | Software has been validated using a test protocol. |
| Field of View / Viewing Angle | "full 60° viewing angle at a depth of up to 6.0cm (sufficient for peripheral vascular)" - claimed to provide a greater field of view than predicate. |
| Storage Capacity | "virtually unlimited storage (tens of thousands of images on tablet pc hard drive and ability to connect external hard drives if additional storage is required)" - significantly greater than predicate device's 74 images. |
| Intended Use Equivalence | The device's intended use for peripheral vascular structures for ultrasound guidance for needle/catheter placement is considered substantially equivalent to the predicate Interson SR 7.5 MHz USB Ultrasound Probe System (K070907) and the Sonosite iLook 25 Personal Imaging Tool (K021628), with some intended use limitations compared to predicates. |
Study Information
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a "test set" in the context of clinical performance data for metrics like sensitivity/specificity. The measurement validation was done using "wire phantoms."
- Data Provenance: The studies mentioned are non-clinical (laboratory testing using phantoms and compliance with international standards). No patient data is mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for measurement accuracy was established by the known dimensions/properties of "wire phantoms." For safety standards, the ground truth is the standard's requirements.
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Adjudication method for the test set:
- Not applicable. The non-clinical tests involved direct measurement against known standards or physical properties.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a traditional ultrasound imaging device, not an AI/ML device. Therefore, an MRMC study for AI assistance is not applicable and was not performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a traditional ultrasound imaging device. The "algorithm" here refers to the system's software functionality, which was validated, but not as a standalone AI diagnostic tool.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For measurement accuracy: Wire phantoms (known physical dimensions).
- For safety and electromagnetic compatibility: International standards (IEC 60601 series).
- For software validation: Test protocols designed to verify software functionality.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no "training set" in the context of machine learning.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/ML model.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.